On January 6, 2021, EPA issued in final its rule titled “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” The rule establishes how EPA will consider the availability of dose-response data underlying pivotal science used in its significant regulatory actions and influential scientific information. Under this rule, EPA will give greater consideration to studies where underlying dose-response data are available with sufficient independent validation. The rule also requires EPA to identify and make publicly available the science that serves as a basis for its regulatory decisions and actions at the draft stage to the extent practicable. Peer review required for pivotal science and criteria for the EPA Administrator to exempt certain studies from the rulemaking requirements are also part of the final rule. The rule became effective on January 6, 2021.
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